Lopinavir ritonavir how supplied
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]
How Supplied
KALETRA® (lopinavir/ritonavir) Film-Coated tablets and Oral Solution are available in the following strengths and package sizes:
KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir
Yellow film-coated ovaloid tablets debossed with the “a” logo and the code KA:
Bottles of 120 tablets ….…………… (NDC 0074-6799-22)
Recommended Storage
Store KALETRA film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59° to 86°F)[see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (250 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (250 mL or less) for longer than 2 weeks is not recommended.
KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir
Pale yellow film-coated ovaloid tablets debossed with the “a” logo and the code KC:
Bottles of 60 tablets ….…………… (NDC 0074-0522-60)
Recommended Storage
Store KALETRA film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59° to 86°F)[see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (100 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (100 mL or less) for longer than 2 weeks is not recommended.
KALETRA Oral Solution
KALETRA (lopinavir/ritonavir) oral solution is a light yellow to orange colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir/100 mg ritonavir per 5 mL (80 mg lopinavir/20 mg ritonavir per mL) packaged with a marked dosing cup in the following size:
160 mL bottle……………………………….(NDC 0074-3956-46)
Recommended Storage
Store KALETRA oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.[1]
References
- ↑ "KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]". Text " accessdate" ignored (help)
Adapted from the FDA Package Insert.